Sobi and Biogen Receive Positive Opinion from CHMP for Alprolix® (rFIXFc) for the Treatment of Hemophilia B

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"We are already seeing the benefits that Fc fusion technology can offer through our recent EU launch of Elocta® for people with hemophilia A. We are excited at the prospect of also offering the possibility for prolonged protection and reduced treatment burden to the hemophilia B community with Alprolix."

STOCKHOLM & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Swedish
Orphan Biovitrum AB (publ) (Sobi™) (STO: SOBI) and Biogen
(NASDAQ: BIIB) received a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) recommending that marketing authorisation be granted for Alprolix®
(rFIXFc), a recombinant factor IX Fc fusion protein therapy for the
treatment of hemophilia B. If approved, Alprolix would be among the
first therapies in the European Union (EU) to offer people living with
hemophilia B prolonged protection against bleeding episodes with
prophylactic dosing intervals.

“This positive opinion marks an important step in our efforts to bring
treatment innovation to people with hemophilia in Europe and around the
world,” said Krassimir Mitchev, M.D., Ph.D., vice president and medical
therapeutic area head of Haemophilia at Sobi. “We are already seeing the
benefits that Fc fusion technology can offer through our recent EU
launch of Elocta® for people with hemophilia A. We are
excited at the prospect of also offering the possibility for prolonged
protection and reduced treatment burden to the hemophilia B community
with Alprolix.”

The positive opinion was based on results from two global, Phase 3
clinical trials that demonstrated the efficacy, safety and
pharmacokinetics of Alprolix for hemophilia B: the pivotal B-LONG study
for previously treated adults and adolescents, and the Kids B-LONG study
for previously treated children under age 12. The CHMP's recommendation
is now referred to the European Commission (EC), which grants marketing
authorisation for medicines in the EU.

“Therapies that offer prolonged protection from bleeds are changing the
way many approach treatment of hemophilia,” said Gilmore O’Neill, M.D.,
senior vice president, Drug Innovation Units at Biogen. “We are proud to
work with Sobi to continue bringing to Europe these innovative Fc fusion
therapies, which are grounded in the most robust real-world experience
of any prolonged circulation factor therapies to date.”

Sobi and Biogen are collaborators in the development and
commercialisation of Alprolix for hemophilia B. Sobi has final
development and commercialisation rights in the Sobi territory
(essentially Europe, North Africa, Russia and most Middle Eastern
markets). Biogen leads development and manufacturing for Alprolix and
has commercialisation rights in North America and all other regions in
the world excluding the Sobi territory.

About Hemophilia BHemophilia B is caused by having
substantially reduced or no factor IX activity, which is needed for
normal blood clotting.1 The World Federation of Hemophilia
estimates that approximately 28,000 people are currently diagnosed with
hemophilia B worldwide.2

People with hemophilia B may experience bleeding episodes in joints and
muscles that cause pain, decreased mobility and irreversible joint
damage. In the worst cases, these bleeding episodes can cause organ
bleeds and life-threatening hemorrhages. Infusions of factor IX
temporarily replace clotting factors necessary to resolve bleeding and,
when used prophylactically, to prevent new bleeding episodes.1

About Alprolix®Alprolix is a recombinant
clotting factor therapy developed for hemophilia B by fusing factor IX
to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a
protein commonly found in the body). This enables Alprolix to use a
naturally occurring pathway to prolong the time the therapy remains in
the body. While Fc fusion has been used for more than 15 years, Sobi and
Biogen are the first companies to utilise it in the treatment of
hemophilia.

Alprolix is currently approved for the treatment of hemophilia B in the
U.S., Canada, Japan, Australia and New Zealand, where it was the first
hemophilia B therapy approved to provide prolonged protection from
bleeds. As with any infused protein, allergic type hypersensitivity
reactions and development of inhibitors may occur following
administration of Alprolix.

About BiogenThrough cutting-edge science and medicine,
Biogen discovers, develops and delivers worldwide innovative therapies
for people living with serious neurological, autoimmune and rare
diseases. Founded in 1978, Biogen is one of the world’s oldest
independent biotechnology companies and patients worldwide benefit from
its leading multiple sclerosis and innovative hemophilia therapies. For
more information, please visit www.biogen.com.
Follow us on Twitter.

About Sobi™Sobi is an international speciality healthcare
company dedicated to rare diseases. Our mission is to develop and
deliver innovative therapies and services to improve the lives of
patients. The product portfolio is primary focused on Haemophilia,
Inflammation and Genetic diseases. We also market a portfolio of
speciality and rare disease products for partner companies across
Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry and
biologics manufacturing. In 2015, Sobi had total revenues of SEK 3.2
billion (USD 385 M) and approximately 700 employees. The share
(STO:SOBI) is listed on NASDAQ OMX Stockholm. More information is
available at www.sobi.com.

Biogen Safe HarborThis press release contains
forward-looking statements, including statements about the potential
benefits of ALPROLIX, and its potential approvability in the EU. These
statements may be identified by words such as “believe,” “expect,”
“may,” “plan,” “potential,” “will,” and similar expressions, and are
based on our current beliefs and expectations. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that unexpected concerns may arise from additional data
or analysis, regulatory authorities may require additional data or
information or further studies, or may fail to approve, or refuse to
approve, or may delay approval of our drug candidates, or we may
encounter other unexpected hurdles. For more detailed information on the
risks and uncertainties associated with our drug development and
commercialization activities, please review the Risk Factors section of
our most recent annual or quarterly report filed with the Securities and
Exchange Commission. Any forward-looking statements speak only as of the
date of this press release and we assume no obligation to update any
forward-looking statements, whether as a result of new information,
future events, or otherwise.